Newsletter | February 6, 2014

02.06.14 -- 2014 Trends In Strategic Outsourcing: Changes In Partner Selection

Pharmaceutical Online Newsletter
Departments:
QA/QC Critical Environments Inspection
Logistics Packaging Manufacturing
» Featured Magazine Article
2014 Trends In Strategic Outsourcing: Changes In Partner Selection
By Kate Hammeke, Director of Marketing Intelligence, Nice Insight
The 2014 results from Nice Insight’s annual pharmaceutical and biotechnology outsourcing survey show positive news for both sides of outsourcing relationships. Just as there was an increase from 2012 to 2013 (up 7 percent, from 31 percent to 38 percent) in respondents with an outsourcing expenditure between $10 million and $50 million, there was another 9 percent increase in this expenditure bracket for the year ahead. Slightly under half of all survey respondents (47 percent) stated they will spend between $10 million and $50 million on outsourced projects in 2014.
Featured Focus: QA/QC
Deconstructing The Blue-Dye Leak Test Method
By Oliver Stauffer, PTI Packaging and Inspection Systems
Blister package manufacturing for tablets and capsules has process and material parameters that are unique to each product. Barrier properties of blister packaging are primarily designed to eliminate moisture ingress, a result of H2O molecules passing through micro-leaks over extended periods of time.
WHITE PAPER: The Integrity Of Pharmaceutical Packaging: Laser-Based Technology vs.Conventional Blue-Dye Leak Testing
By Dr. Dorian Dixon, Nanotechnology and Advanced Materials Institute, University of Ulster
A new white paper on the integrity of pharmaceutical packaging, by a leading packaging expert from the University of Ulster, Dr. Dorian Dixon, has established that existing methods for testing the seal integrity of blister packs are not as accurate as newer, technology-based test equipment.
APPLICATION NOTE: Particle Monitoring In Pharmaceutical Cleanrooms
By Morgan Polen, VP of Application Technology, Lighthouse Worldwide Solutions
Environmental monitoring is an important aspect of regulatory and quality control in the production of pharmaceuticals. The manufacturing environment must be controlled and monitored during the production of drugs. Final drug products must be sterile and free from contamination.
DATASHEET: Rotating Load Sterilizers
By Fedegari Group
BROCHURE: Custom Isolators And Containment Systems
» Critical Environments
WHITE PAPER: Use Of Hydrogen Peroxide Vapor Biodecontamination Technology For Facility Commissioning
By Arthur Papineau, BS ChE, MBA; and John Klostermyer, Ph.D., STERIS Life Sciences
Whether it is a new laboratory research facility or renovation of an existing facility, a sound commissioning process is vital to start-up success.
WHITE PAPER: How To Properly Vacuum Your Cleanroom
PRODUCT: Flexible And Modular Pharmaceutical Pods
PRODUCT: Laser Diffraction Particle Size Analyzer
PRODUCT: Pharmaceutical Rotating Load Sterilizers
» Inspection
WHITE PAPER: Tips For Responding To FDA Form 483 Inspectional Observations
By Bruce McDuffee, Marketing Manager, Vaisala Life Science Division
According to the FDA document titled Investigations Operations Manual (IOM), the form FDA 483 INSPECTIONAL OBSERVATIONS is intended for use in notifying the inspected establishment's top management, in writing, of "... significant objectionable conditions, relating to products and/or processes, or other violations of the FD&C Act and related Acts which were observed during the inspection." This statement, and other background information, can be found in section 5.2.3: Reports of Observations of the IOM.
BROCHURE: Leak Testing Equipment For Packaging And Closure Containers
PRODUCT: Liquid Automated Inspection Machines
PRODUCT: Tablet Visual Inspection With Color And 3D High-Speed
» Logistics
ARTICLE: New Regulations: Logistics And The Pharmaceutical Supply Chain
By Jeff Clark, 7P Solutions™, LLC
The transportation and logistics world is accustomed to complying with regulations — from the Department of Transportation (DOT), to the International Air Transport Association (IATA), as well as country-specific import and export regulations. With the implementation of Good Distribution Practices (GDP) in the European Union, it is inevitable that the U.S. will follow suit, and the Food and Drug Administration (FDA) will adopt GDP as well. This is the foundation for securing the "identity, strength, quality, and purity" of all pharmaceutical products as defined in 21 CFR Part 211, Current Good Manufacturing Practices for Finished Pharmaceuticals (cGMP).
ARTICLE: Supply Chain Visibility Is A Key Part Of Delivering Proof Of Product Integrity
ARTICLE: New Investments In Asia Enable Envirotainer To Respond To High Market Demand
BROCHURE: Event-Based Asset Tracking Solution
PRODUCT: ISCLabs: Thermal Packaging Design And Testing Services
» Packaging
WHITE PAPER: Large-Scale Biodecontamination With Hydrogen Peroxide Vapor
DATASHEET: Canister Dispenser
By Multisorb Technologies
BROCHURE: In-Canada Clinical Trial Distribution
PRODUCT: Contract Packaging: Inventory Management
PRODUCT: Used Blister Packaging Equipment
» Manufacturing
GUEST COLUMN: Maximize Return; Minimize Risk (Important Things To Consider When Closing A Lab)
By Tom Burton, President Liquidity Services' Capital Asset Group
Whether a small enterprise or large institution, many organizations have and will be faced with the challenge of closing a lab. No matter what the size or scope of the closure, the person tasked with closing the facility faces a daunting assignment: millions of dollars in real estate, laboratory equipment, and research devices will need to be redeployed, sold, or disposed of.
WHITE PAPER: Flexible Containment Solutions Guide: Document Transfer Enclosure
PRODUCT: Roller Compaction: Process Analytical Tools
PRODUCT: A Guide To Homogenization In The Pharma, Biotech, And Cosmetic Industries
PRODUCT: Multipurpose Isolators
PRODUCT: High-Performance HMI And Alarm Management
UPCOMING TRAINING

Data Integrity And Manufacturing: Detecting And Mitigating Risk
Date: Wednesday, February 12, 2014 • Time: 1pm – 2:30pm EST

Quality By Design (QbD): Successful Implementation For Pharmaceutical Development And Manufacturing
Date: Tuesday, February 25, 2014 • Time: 1pm – 2:30pm EST
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